Select Committee on Science and Technology Sixth Report


Members visiting Allergy Therapeutics were: Lord Broers, Lord Colwyn, Baroness Finlay of Llandaff (Chairman), Lord Rea, Earl of Selborne, Lord Taverne. In attendance: Miss Sarah Jones (Clerk).

2 February 2007

The Committee was welcomed by Mr Keith Carter, Chief Executive Officer. The company had previously traded under the Bencard brand, and SmithKline Beecham, before a management buy-in during 1998 had formed Allergy Therapeutics.

Mr Ray Keeling, Head of Supply Operations, outlined the different types of products the business supplied. The company produced a range of therapeutic medicines, provocation solutions, skin prick and patch tests, but focussed mainly on specific immunotherapy. He noted that although immunotherapy had largely been developed in the United Kingdom, the NHS made very little use of the treatment. Allergy Therapeutics therefore sold most of its products abroad. In addition to standard products kept in stock, the company also produced named-patient products, manufactured as a "semi-stock," to which three or four allergens could be added according to each patient's prescription.

Dr Bev Lees, Head of Science, gave a brief overview of the research and development program at Allergy Therapeutics. The company had developed PollinexQuattro, an ultra-short course of subcutaneous immunotherapy, to treat seasonal allergic rhinitis with only four pre-seasonal injections over three weeks. It was claimed that the adjuvants, 3-deacylated monophosphoryl lipid A (MPL®) and L-tyrosine, within the product enabled it to be effective within such a short course. Three formulations of PollinexQuattro had been developed to treat rhinitis caused by either grass, tree or ragweed pollens. The product was available on a named-patient basis in Austria, Germany, Greece, Italy, Portugal, Spain and the United Kingdom. However, it still awaited the results of phase III clinical trials and the MHRA would then need to approve it before it could be used routinely within the NHS. The company also had other PollinexQuattro treatments on the market as named-patient products, which were used to treat allergies to rarer substances such as olives and plantain.

Mr Rick Poland, Production, Engineering and Technical Manager, described the process of converting raw pollen into a series of dilutions for immunotherapy treatments. Various pollens were imported from around the world, and each had to obtain a certificate of analysis before it could be used. This certificate verified that the pollen was not contaminated and helped to ensure that the treatment would be safe and effective.

The company referred to immunotherapy products as "vaccines." This term was used because the treatments modified the immune system. However, the treatments were therapeutic vaccines (which aimed to suppress the immune response once a disease had developed) rather than prophylactic vaccines (which induced the immune system to prevent diseases occurring).

The Committee was given a tour of the Noon Building, a new manufacturing facility which had opened in January 2007. The licensed manufacturing facility could produce a range of sterilised parenteral products, and the building also contained the inspection, labelling, packaging and despatch operations. The Committee viewed individual workstations where named-patient products were prepared. Video surveillance and computer systems had been installed in each station to monitor production of the treatments.

Dr Murray Skinner, Development Manager, described how the development team devised and supported new and existing products and practices used within the company. The team's work included the validation of assays used in research, obtaining scientific data to support the company's manufacturing processes, and supporting trials to ensure that products met the standards required of them.

Mr Carter noted that the majority of allergy treatments used in the United Kingdom, such as antihistamines and corticosteroids, only offered short-term relief from symptoms and worked during the final stages of an allergic reaction. But immunotherapy modified the immune system to interrupt the beginning of the allergic reaction and could prevent the symptoms of allergic disease for many years. Although initially expensive, it was thought that immunotherapy could therefore save the NHS money in the long-term. Furthermore, studies had suggested that the use of immunotherapy in rhinitis patients could prevent the development of asthma, which could produce a further saving in terms of treatment costs.

Mr Carter felt that immunotherapy was not used in the United Kingdom as much as it could be, partly because it involved long courses of injections, and partly because some clinicians were fearful of adverse systemic reactions. The company had therefore invested heavily in the development of PollinexQuattro because it believed that the treatment could answer both of these problems, and felt that in the future all specialists in secondary care should be able to administer it. However, it would not be suitable for use by GPs.

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